Sermorelin: where it stands with the FDA, and what it costs
Once sold as an FDA-approved drug (Geref), which its maker withdrew from the market; what clinics prescribe today is compounded.
Prices by form:injections (329)tablets (31)troches (30)nasal spray (11)
Go to clinicLowest per monthSermorelin tablets
T·TIME · ≈ $69/mo ($207 for 90 days)
Go to clinicLowest at a clinic we link toSermorelin tablets
bmiMD · $99/mo
Where Sermorelin stands today
Sermorelin acetate was FDA-approved as GEREF (EMD Serono). GEREF is discontinued; FDA withdrew the approvals at the sponsor's request in 2009 and in 2013 determined they were not withdrawn for safety or effectiveness reasons. FDA's 503B list marks sermorelin acetate as a component of an FDA-approved drug and places it in 503B Category 1. It is not in any 503A category and no advisory committee has voted on it.
FDA-approved products
GEREF (sermorelin acetate) for injection, 0.5 mg and 1 mg/vial, EMD Serono, Inc., approved 1997-09-26 (NDA 020443). Discontinued; approval withdrawn at the sponsor's request effective June 18, 2009; FDA determined in 2013 it was not withdrawn for safety or effectiveness reasons.
“GEREF SERMORELIN ACETATE EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued”
GEREF (sermorelin acetate) injection, 0.05 mg/amp (diagnostic), EMD Serono, approved 1990-12-28 (NDA 019863). Discontinued (same 2009 withdrawal and 2013 determination).
“GEREF SERMORELIN ACETATE EQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued”
FDA determination on GEREF (Federal Register, March 4, 2013), FDA. Determination notice.
“were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection ... FDA announced that it was withdrawing approval of NDA 19-863 and NDA 20-443, effective June 18, 2009.”
For pharmacies compounding one patient's prescription (section 503A)
Not in any 503A category and not on the 503A bulks list. Its active ingredient is a component of an FDA-approved (now discontinued) drug, GEREF, which is the 503A route for a substance without a monograph (FDA marks it as such on its 503B list).
“**Designates bulk drug substances that are components of FDA approved drugs ... Sermorelin Acetate**”
How FDA says to tell whether a substance is a component of an approved drug
“To determine if a bulk drug substance is a component of an FDA-approved drug product, see the FDA's Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations”
For outsourcing facilities (section 503B)
Category 1 (Bulk Drug Substances Under Evaluation), marked ** as a component of an FDA-approved drug; not on the 503B bulks list.
“503B Category 1: Bulk Drug Substances Under Evaluation ... Sermorelin Acetate**”
What 503B Category 1 means
“FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in category 1 provided that the conditions described in the guidance document are met.”
FDA warnings, recalls and letters
10 December 2024: Warning letter; FDA treats 'research use only' peptides marketed for people, including sermorelin, as drugs for human use. (Xcel Research LLC (online 'research use only' seller)).
“Despite statements on your product labeling marketing your products, “FOR RESEARCH USE ONLY” and “NOT INTENDED FOR HUMAN USE,” evidence obtained from your website establishes that your products are intended to be drugs for human use.”
21 October 2025: Recall of sermorelin. Class II; recall initiated 2025-07-30, classified 2025-10-21, distributed nationwide. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose ... Lack of Assurance of Sterility”
8 October 2026: Recall of compounded sermorelin acetate syringes. Class II; initiated 2026-09-10, classified 2026-10-08. (Carolina Infusion, LLC, Ridgeland, SC).
“SERMORELIN ACETATE 1 MG/ML INJECTABLE ... Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.”
13 October 2026: Recall of compounded sermorelin 1 mg/mL vials. Class II; initiated 2026-09-25, classified 2026-10-13. (Houston Rx LLC, Houston, TX).
“Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution ... Lack of process control”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)”
Our reading
Because sermorelin acetate is a component of an FDA-approved drug, a 503A pharmacy may compound it from a 510-registered source for a patient-specific prescription without needing the bulks list, as for any approved-drug ingredient; a 503B facility may use it under the 503B Category 1 policy. Whether a component of an application whose approval was withdrawn still counts is FDA's reading of the statute; FDA's own 503B document labels it a component, and we found no FDA statement to the contrary.
Every source above was checked again on 14 November 2026.
What 371 clinics charge
- T·TIMESermorelin tablets≈ $69/mo$207 for 90 days
- Rolling WellnessSermorelin injection (1mg/ml)≈ $77/mo$179 for 70 days
- LeanMedsSermorelin injection (2mg)$79/mo
- Ascend VitalitySermorelin injectionfrom $79/mosupply not stated, counted as 4 weeks: ≈ $85 per 30 days
- Contour HealthSermorelin injectionfrom $90for 30 days
What Sermorelin is
- What it is
- Growth hormone-releasing hormone (GHRH) analog
- How it works
- The first 29 amino acids of human growth hormone-releasing hormone. It prompts the pituitary to release the body's own growth hormone.
- How it is given
- Subcutaneous injection; also sold as troches and capsules
- Also called
- sermorelin acetate, GRF 1-29
- Availability
- The branded product, Geref, is no longer marketed in the US; current prescriptions are filled by compounding pharmacies.
Sermorelin side by side
About Sermorelin
Is Sermorelin FDA-approved?
No. No FDA-approved drug contains Sermorelin. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Sermorelin legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. Sermorelin acetate was FDA-approved as GEREF (EMD Serono). GEREF is discontinued; FDA withdrew the approvals at the sponsor's request in 2009 and in 2013 determined they were not withdrawn for safety or effectiveness reasons. FDA's 503B list marks sermorelin acetate as a component of an FDA-approved drug and places it in 503B Category 1. It is not in any 503A category and no advisory committee has voted on it.
How much does Sermorelin cost?
371 clinics publish a price. The lowest that compares per month is about $69 a month ($207 for 90 days) at T·TIME, and the middle of 309 clinics' lowest monthly prices is about $179. What a month buys differs by clinic, so each price lists what it includes. every Sermorelin price
What forms does Sermorelin come in?
Clinics sell it as injection (329 prices), other (62 prices), tablets (31 prices), troches (30 prices), nasal spray (11 prices), capsules (1 price).